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INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register

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ClinicalTrials.gov Identifier: NCT04381611
Recruitment Status : Recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Kaweh Mansouri, Swiss Vision Network

Brief Summary:
The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.Patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.

Condition or disease
Glaucoma Open-Angle Glaucoma Eye Glaucoma; Drugs Glaucoma, Angle-Closure Glaucoma Secondary Glaucoma, Neovascular Glaucoma Congenital Surgery Glaucoma, Pigmentary Glaucoma Capsulare

Detailed Description:

This study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in Lausanne, Switzerland. The design of the study is longitudinal, observational and comparative. Patients are recruited retrospectively if they attended the research centre before September 2018, and prospectively if they attend the centre from this month onwards. Their inclusion does not affect their care, treatment choice or follow-up. All data of recruited patients is be kept in their medical notes until a specific analysis is launched. Data is then exported from their medical notes into a coded database for analysis. At the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised.

Data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed.

To ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a Clinical Research Associate. Conformity of the process and recorded data will be confirmed by regular internal auditing. For quality assurance the Ethics Committee may visit the research sites. Direct access to the source data and all project related files and documents must be granted on such occasions.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2030
Estimated Study Completion Date : January 15, 2030


Group/Cohort
Primary Glaucoma
Glaucoma Surgery
Glaucoma Laser
Glaucoma Surgery Combined
Glaucoma treatment
Glaucoma imaging
Glaucoma co-morbidity
Glaucoma untreated
Glaucoma Suspect
Secondary Glaucoma



Primary Outcome Measures :
  1. Number of patients with IOP reduction mmHg [ Time Frame: 12 month ]
    Final Intra Ocular Pressure <20% compared to baseline

  2. Patients with quantitative OCT variations ( RNFL, μm) [ Time Frame: 12 month ]
    Variation of RNFL before and after treatment ( laser, surgery, drug..)

  3. Number of patients with quantitative VF variation ( MD, dB) [ Time Frame: 12 month ]
    Visual Field MD variation before and after treatment ( laser, surgery, drug..)

  4. Number of patients with quantitative VF variation (LV, dB) [ Time Frame: 12 months ]
    Visual Field MD variation before and after treatment ( laser, surgery, drug..)


Secondary Outcome Measures :
  1. Number of operations received by a patients [ Time Frame: 12 month ]
    Number of operations undertaken by each patient

  2. Number of patients undergoing a specific ocular surgical or laser procedure [ Time Frame: 12 month ]
    Number of patients undertaking different types of ocular procedures ( deep sclerectomy, cataract, LPI, SLT,...)

  3. Number of lowering IOP drugs ( molecules) taken by each patient [ Time Frame: 12 month ]
    Number of molecules used by each patient (e.g Cosopt: 2 molecules, Xalatan: 1...)

  4. Anterior segment OCT variations: ACA (°), SSA (°) [ Time Frame: 12 month ]
    variations of these measurements before and after procedure ( surgery or laser)

  5. Anterior segment OCT variations: AOD (mm) [ Time Frame: 12 month ]
    variations of these measurements before and after procedure ( surgery or laser)

  6. Anterior segment OCT variations: TISA (mm2) [ Time Frame: 12 month ]
    variations of these measurements before and after procedure ( surgery or laser)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic
Criteria

Inclusion Criteria:

  • Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP > 24 mmHg, medicated or not)
  • Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic
  • Able and willing to provide informed written or verbal consent

Exclusion Criteria:

  • Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381611


Contacts
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Contact: Kaweh Mansouri 0216193939 ext 0041 KMansouri@gsvn.ch
Contact: André Mermoud 0216193939 ext 0041 amermoud@gsvn.ch

Locations
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Switzerland
SwissVisio Montchoisi Recruiting
Lausanne, Vaud, Switzerland, 1006
Contact: Kaweh Mansouri    0216193939 ext 0041    KMansouri@gsvn.ch   
Sponsors and Collaborators
dr. Kaweh Mansouri
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Responsible Party: dr. Kaweh Mansouri, Professor UC Denver, Swiss Vision Network
ClinicalTrials.gov Identifier: NCT04381611    
Other Study ID Numbers: INTEGRAL
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Glaucoma, Open-Angle
Hydrophthalmos
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Iris Diseases
Uveal Diseases